In order correct sight defects, such as myopia, hyperopia and astigmatism, optometrists and/or ophthalmologists perform refractive laser eye surgery on a patient's cornea. Owing to the high level of precision that is required for consistently successful operations, optometrists must accurately determine the type and extent of defects, or aberrations, for each patient prior to laser correction. Consequently, patients undergoing corneal treatment for sight defects are subjected to a wide array of tests to determine various optometric parameters unique to the particular patient. Data consisting of optometric parameters such as radii of curvature, pupil size, cornea size, pupillary distances (near, intermediate and distant), lens segment type, optical transmittance, channel width, sphere power, cylinder power and axis, prism power and base (vertical and horizontal), viewing distances, etc. assist in precisely describing a patient's eye including lower and higher-order aberrations. This data is later used by optometrists and/or ophthalmologists in various procedures or operations. For example, the data can be used to determine an ablation pattern for an excimer laser in a refractive laser eye surgery such as laser-assisted in situ keratomileusis (LASIK).
In determining the various optometric parameters, optometrists typically have many different measuring devices at their disposal, such as lensmeters, autorefractors, phoropters, ophthalmotonometry, corneal topographers, wavefront aberrometers, etc. Each of these devices presents the ascertained measurement data in different ways and utilizes widely varied techniques to document the results, such as displaying, e.g., on a monitor, or printing. Further, these devices, which obtain different optometric parameters, are designed and manufactured by different entities and have little to no compatibility with one another. Moreover, each device utilizes unique customized displays for patient information, measurement values and other data. The different ways of displaying the data can result in confusion and misinterpretation.
In addition to the measurement devices, certain optometric parameters are determined manually and/or require a subjective determination of a trained employee. Patient identification information such as name, maiden name, date of birth, social security number, driver's license number, address, patient identification number and the like are normally provided in a standard handwritten form filled out by the patient or transcribed by hand prior to the patient's examination by a qualified employee. Various other examination methods also carried out by qualified employees, such as optometrists, ophthalmologists or opticians, are performed manually, at least in part, and provide standard forms for recording measurement values by hand. For example, an attending physician typically uses corrective lenses (probe glasses) and other aids in making a subjective refraction determination and records the measurement results by hand on a standard form suited for that purpose.
In order to provide a single source for this data, it is usually transcribed by hand and/or read off the customized displays and is manually entered into a patient's medical records by medical personnel. In addition to being time-consuming, the transfer of data from the various different measurement devices entails a substantial risk of error, misinterpretation, data loss, conversion and patient mix-up. For example, measurement values could be read off or transcribed inaccurately or the handwritten measurement values could be misinterpreted, e.g., due to poor handwriting, or entered wrong into the patient's medical records.
This risk is also compounded by a subsequent manual transfer of requisite measurement data from a patient's medical records to other devices, such as a surgical planning tool for creating an ablation pattern of a refractive laser eye surgery or cut geometry for femtosecond-refractive treatments (FLEx/SMILE). Since the diagnostic data is used in planning a correction of sight defects, it must be ensured that the data is both accurate and recent. However, with the data being entered from multiple sources and being transferred to multiple different devices, it is difficult to maintain accuracy throughout the different stages. This is especially true in the typical case where multiple different medical personnel (from clerks and assistants to ophthalmologists) and patients are involved. From obtaining the requisite diagnostic data to planning a surgery, multiple handwritten records are created by different people which other persons transferring the data must interpret and enter correctly at each phase.
One planning tool, CRS-MASTER by Carl Zeiss Meditec AG, integrates measurement data from an aberrometer and corneal topographer into an electronic planning system for a refractive laser eye surgery. While such a planning tool is designed for automated import of data created by compatible measurement devices and helps to minimize the risk of error, the electronic planning is still normally preceded by an initial handwritten documentation phase. This may be due to the fact that some measurements are performed manually without access to the planning tool. Further, diagnostic data from incompatible measurement devices must still be obtained and transferred along with the other handwritten documentation to a patient's medical records. This could result in a segregation of data and still entails the same initial risk of loss or error.
The recording of measurement values by hand and the manual transfer of data from multiple different measurement devices (having different viewing apparatuses and utilizing different forms of data display) to medical records and/or from the medical records to a surgical planning tool entails a substantial risk of clerical and transcription errors such as misinterpretation, e.g., of writing or of the particular data display, or data loss/conversion during a subsequent manual transfer. Specifically, the following errors can arise during the following steps from diagnosis to treatment:
Step 1, obtaining patient identification data and measurement values: Error 1 (ERR1), an error occurs when assigning recorded data to a patient; Error 2 (ERR2), an error occurs when reading off data from a measurement device; or Error 7 (ERR7), an error occurs when there is no assignment of the measurement data by a qualified collector.
Step 2, transferring the measurement data to a patient's medical records: Error 3 (ERR3), an error occurs when manually entering the data into the respective medical record; or Error 6 (ERR6), an error occurs when temporally assigning the optometric parameters.
Step 3, transferring the measurement data from medical records to a diagnostic or planning tool: Error 4 (ERR4), an error occurs when data in the medical record is misinterpreted; Error 5 (ERR5), an error occurs when manually entering the data into the tool during the computer-assisted processing; Error 6 (ERR6), an error occurs when temporally assigning the optometric parameters; or Error 7 (ERR7), an error occurs when there is no assignment of the measurement data by a qualified collector.
To illustrate the various errors that can occur at different stages from acquiring measurement values to loading them into a planning tool, the following scenario is useful. A collector of data takes an optometric parameter using a measurement device which results in a measurement value of 10.0 dpt for that optometric parameter. However, when transferring the measurement value to the patient's medical record, the location of the data point is inadvertently moved due to an error in reading or transcription such that the measurement value now appears as 1.00 dpt. Then, when consulting the patient's medical record to program the diagnostic data into a planning tool, it is again misinterpreted such that the value of 1.00 dpt is inadvertently read out as 7.00 dpt.
To minimize the risk of such errors, frequent, time-consuming control steps are customarily utilized which typically involve many burdensome manual comparisons and an onerous system of cross-checking data.